A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail

Michael S. Gordon, Shannon Gwin Mitchell, Thomas R. Blue, Frank J. Vocci, Marc J. Fishman, Sean M. Murphy, Kathy Couvillion, Kelly Maher, Danielle Ryan, Kevin Wenzel, Martha L. Danner, Daniel K. Jarvis

Research output: Contribution to journalArticlepeer-review

Abstract

This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.

Original languageEnglish (US)
Article number108241
JournalJournal of Substance Abuse Treatment
DOIs
StateAccepted/In press - 2020
Externally publishedYes

Keywords

  • Extended-release buprenorphine
  • Extended-release naltrexone
  • Jail
  • Justice-involved
  • Medications for opioid use disorders

ASJC Scopus subject areas

  • Phychiatric Mental Health
  • Medicine (miscellaneous)
  • Clinical Psychology
  • Psychiatry and Mental health

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